Prospecto: Information for the Patient

Fenofibrate Teva 200 mg Hard Capsules EFG

Read this prospectus carefully before starting to take the medicine as it contains important information for you.

• Keep this prospectus as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospectus. See section 4.

1.What is Fenofibrate Teva and what it is used for

2.What you need to know before starting to take Fenofibrate Teva

3.How to take Fenofibrate Teva

4.Possible adverse effects

5Storage of Fenofibrate Teva

6.Contents of the pack and additional information

Fenofibrato Teva belongs to a group of medications commonly known as fibrates. These medications are used to decrease the level of fats (lipids) in the blood, for example, fats known as triglycerides.

Fenofibrato Teva is used in conjunction with a low-fat diet and other non-medication treatments such as exercise and weight loss, to decrease blood fat levels.

Fenofibrato Teva may be used in conjunction with other medications (statins) in certain circumstances when a statin alone does not control blood fat levels.

Do not take Fenofibrato Teva

• If you are allergic to fenofibrate or any of the other components of this medication (listed in section 6).
• If you have photosensitivity (an allergic reaction caused by exposure to sunlight or ultraviolet rays) or phototoxic reactions during treatment with fibrates (medications that modify lipid levels) or ketoprofen (an anti-inflammatory medication).
• If you have liver, kidney, or gallbladder problems.
• If you have pancreatitis (inflammation of the pancreas, which causes abdominal pain) not caused by high blood fat levels.

Do not take Fenofibrato Teva if any of the above circumstances apply (or you are unsure), consult your doctor or pharmacist before taking this medication.

Warnings and precautions

Consult your doctor or pharmacist before taking Fenofibrato Teva:

• If you have any liver or kidney problems.
• If you may have liver inflammation (hepatitis): signs include yellowing of the skin and the white of the eyes (jaundice), increased liver enzymes (shown in blood tests), stomach pain, and itching.
• If you have a less active thyroid gland (hypothyroidism).

If any of the above apply (or you are unsure), consult your doctor or pharmacist before taking Fenofibrato Teva.

Muscle effects

Stop taking Fenofibrato Teva and contact your doctor immediately if you experience:

• Unexplained muscle cramps.
• Pain, sensitivity, or muscle weakness when taking this medication.

This is because this medication can cause muscle problems, which can be serious. These problems are rare but include inflammation and muscle degradation. This can cause kidney damage or even death.

Your doctor may perform blood tests to monitor your muscles before and after starting treatment.

The risk of muscle destruction is higher in some patients. In particular, inform your doctor if:

• You have kidney problems.
• You have thyroid problems.
• You have low levels of a certain protein in your blood (hypalbuminemia).
• You are over 70 years old.
• You or a close relative have a hereditary muscle problem.
• You drink large amounts of alcohol.
• You have had muscle problems during treatment with statins or fibrates (such as fenofibrate, bezafibrate, or gemfibrozil).
• You are taking medications called statins to reduce cholesterol (such as simvastatin, atorvastatin, pravastatin, rosuvastatin, or fluvastatin) or other fibrates.

If any of the above apply (or you are unsure), talk to your doctor before taking Fenofibrato Teva.

Children and adolescents

Fenofibrate is not recommended for children and adolescents under 18 years due to insufficient clinical data.

Other medications and Fenofibrato Teva

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

In particular, inform your doctor or pharmacist if you are using any of the following medications:

• Anticoagulants to thin the blood (e.g., warfarin).
• Other medications to control lipid levels (such as statins or fibrates). This is because taking a statin or another fibrate in addition to Fenofibrato Teva may increase the risk of muscle problems (see 'Warnings and precautions' above).
• A particular class of medications to treat diabetes (such as rosiglitazone or pioglitazone).
• Ciclosporin, an immunosuppressant.

If any of the above apply (or you are unsure), consult your doctor or pharmacist before taking Fenofibrato Teva.

Taking Fenofibrato Teva with food and drinks

You should take Fenofibrato Teva with meals, as it will work better than with an empty stomach.

Pregnancy and breastfeeding

Inform your doctor if you are pregnant, think you may be pregnant, or plan to become pregnant. This is because it is not known how Fenofibrato Teva may affect the fetus. Only use Fenofibrato Teva if your doctor tells you to.

Do not use Fenofibrato Teva if you are breastfeeding or plan to breastfeed. This is because it is not known if fenofibrate passes into breast milk.

Driving and operating machinery

Fenofibrato Teva does not affect or insignificantly affects your ability to drive and operate machinery.

Fenofibrato Teva contains sodium

This medication contains less than 1 mmol (23 mg) of sodium per capsule; it is essentially "sodium-free".

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. Consult your doctor or pharmacist if you have doubts.

Your doctor will determine the appropriate dose for you, depending on your condition, your current treatment, and your personal risk profile.

The recommended dose for adults is one capsule per day, including elderly patients.

For proper use of this medication, it is essential to undergo regular medical check-ups.

If you have kidney problems

If you have kidney problems, your doctor may recommend a lower dose. Ask your doctor or pharmacist about this. Other doses and pharmaceutical forms of fenofibrate are available for inadequate dosing with this medication.

If you have liver problems

This medication is not recommended for patients with liver insufficiency due to lack of data.

Use in children and adolescents

Fenofibrate is not recommended for use in children and adolescents under 18 years old, as there is insufficient data available.

Route of administration

Oral route

Swallow the capsules whole with water. It is essential to take the capsules with some food, as they do not act in the same way on an empty stomach.

To treat your elevated cholesterol levels, you must exercise regularly and follow the dietary recommendations given by your doctor while taking this medication.

If you take more Fenofibrate Teva than you should

If you accidentally ingest too many capsules or think someone else has swallowed some, contact your nearest hospital or inform your doctor immediately.

In case of overdose or accidental ingestion, consult your doctor immediately or call the Toxicological Information Service, phone 915 620 420, indicating the medication and the amount ingested.

If you forget to take Fenofibrate Teva

If you forget to take a dose, take the next dose with your next meal. Then continue taking your capsule at your usual time. Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Fenofibrate Teva

Do not stop taking Fenofibrate Teva unless your doctor tells you to or if the capsules make you feel unwell. This is because abnormal levels of fats in the blood need to be treated for a long period of time.

Remember that taking Fenofibrate Teva is important, as is having a low-fat diet and exercising regularly.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicinemay cause side effects, although not everyone will experience them.

Stop taking Fenofibrate Teva and seek immediate medical attention from your doctor if you notice any of the following severe side effects:

Rare:may affect up to 1 in 100 people

• muscle cramps or pain, sensitivity or weakness: these may be symptoms of muscle inflammation and muscle destruction, which can cause kidney damage or even death.
• abdominal pain: this may be a symptom of an inflamed pancreas (pancreatitis).
• chest pain and shortness of breath: this may be a symptom of a blood clot in the lung (pulmonary embolism).
• pain, redness or swelling of the legs: these may be symptoms of a blood clot in the leg (deep vein thrombosis)

Rare:may affect up to 1 in 1,000 people

• allergic reaction – symptoms may include swelling of the face, lips, tongue or throat, which can cause difficulty breathing.
• yellowing of the skin and white of the eyes (jaundice), or an increase in liver enzymes: these may be symptoms of an inflamed liver (hepatitis).

Unknown:cannot be estimated from available data

• severe skin eruption that reddens, peels and swells the skin and resembles a severe burn.
• long-term lung problems.

Stop taking Fenofibrate Teva and seek immediate medical attention from your doctor if you notice any of the above side effects.

Other side effects are:

Consult your doctor or pharmacist if you experience any of the following side effects:

Frequent:may affect up to1 in 10 people

• diarrhea,
• abdominal pain,
• gas (flatulence)
• nausea,
• vomiting,
• high levels of liver enzymes in the blood - seen in blood tests.
• increased homocysteine (excess of this amino acid in the blood has been associated with a higher risk of coronary heart disease, stroke and peripheral vascular disease, although no causal relationship has been established).

Rare:may affect up to1 in 100 people

• headache
• bile stones
• decreased libido
• skin rash, itching or red patches on the skin
• increased creatinine (produced by the kidneys); appears in blood tests.

Rare:may affect up to1 in 1,000 people

• hair loss
• increased urea (produced by the kidneys) - appears in blood tests
• skin more sensitive to sunlight, sunlamps and sunbeds
• decrease in hemoglobin (which transports oxygen in the blood) and decrease in white blood cells - seen in blood tests.

Unknown:cannot be estimated from available data

• muscle wasting
• complications of bile stones
• feeling of exhaustion (fatigue)

Consult your doctor or pharmacist if you experience any of the side effects listed above.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use website:www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of the medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appearson the blister pack and on the outer caseafter CAD. The expiration date is the last day of the month indicated.

Store in the original packaging to protect it from light. Store the blister pack in the outer carton.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Fenofibrate Teva Composition

• The active ingredient is fenofibrate. Each capsule contains 200 mg of fenofibrate
• The other components are: sodium lauryl sulfate, povidone, pregelatinized cornstarch, crospovidone, sodium croscarmellose, sodium starch glycolate (potato), anhydrous colloidal silica, and sodium stearoyl fumarate. The capsule contains gelatin, titanium dioxide (E171), allura red AC, and printed ink containing shellac, iron oxide black, and propylene glycol.

Appearance of Fenofibrate Teva and content of the container

Hard gelatin capsule with a red-orange opaque cap and body, filled with a white or almost white powder with small agglomerates, printed with FM200 on the body and cap.

• Fenofibrate Teva 200 mg is presented in a box of 1, 20, 28, 30, 50, 60, 84, 90, 100, or 300 (10x30) capsules.

Not all container sizes may be marketed.

Marketing Authorization Holder

Teva Pharma, S.L.U.

C/Anabel Segura 11, Edificio Albatros B, 1st Floor

28108 Alcobendas, Madrid

Manufacturers

Pharmachemie B.V.

Swensweg 5, 2031 GA Haarlem

Holland

TEVA Pharmaceutical Works Private Limited Company

Pallagi út 13, 4042 Debrecen

Hungary

Teva Operations Poland Sp. z.o.o.

ul. Mogilska, 80

31-546 Krakow

Poland

Teva Czech Industries s.r.o.

Ostravska 29, c.p. 305, Building No 80 Small OSD and building No 881 NOSD

747 70 Opava-Komarov;

Czech Republic

This leaflet has been revised in March 2024

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/

You can access detailed and updated information on this medicine by scanning the QR code included in the packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/72705/P_72705.html